Regional Blocks for Lateral Condyle Fractures

NCT ID: NCT03796572

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-16
• Study Completion Date: 2027-03-07

Brief Summary

The purpose of this study is to investigate the post-operative pain control in pediatric patients with closed lateral condyle fractures who undergo open reduction and percutaneous pinning. Patients will be randomized into one of two groups. Group 1 will receive an infraclavicular nerve block to the affected extremity by a fellowship trained pediatric anesthesiologist prior to surgery. Group 2 will undergo the Orthopaedic Institute of Children's (OIC) standard preoperative protocol. Post-operative pain management will be the same for both groups per standard protocol. Pain level will be assessed post-operatively using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. All patients in both groups will receive standard oxycodone solution prescriptions post-operatively as per typical protocol. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery and 1st post-op visit). This study is being conducted in hopes of developing comprehensive pain management protocols to reduce opioid consumption after surgical fixations of displaced lateral condyle fractures if the study can show that patients are more satisfied and require less opioid medication when receiving preoperative regional anesthesia.

Detailed Description

This is a double-blinded, randomized controlled trial evaluating the analgesic efficacy of infraclavicular regional blocks for postoperative pain control in patients following open reduction and percutaneous pinning for isolated closed lateral condyle fractures. Each patient will be evaluated initially at OIC's pediatric urgent care center and placed in a long arm splint with instructions to elevate the affected arm. Patients will not be discharged with any prescriptions for narcotic pain medication and will be instructed to take weight-based doses of acetaminophen and/or ibuprofen for pain control as needed.

All patients age 4-12 with isolated closed Weiss classification type II and III (>2mm displacement) lateral condyle fractures requiring fixation (e.g. satisfactory reduction not achieved with closed reduction and casting) will be approached for participation in the study. Demographic data (age, gender, weight, height, ethnicity, primary language spoken at home, insurance type) will be obtained through chart review on each included patient.

The exclusion criteria include open fractures, fractures with concomitant vascular or neurologic deficit, pathologic fractures, those presenting with concomitant injuries, swelling requiring post-operative hospitalization for monitoring, any known history of allergies to ropivacaine or oxycodone, and patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised. Informed consent will be obtained from all parents who wish to participate in the study, and assent will be obtained from patients when possible. If parents refuse participation in the study, the reason for refusal will be documented, and their child's care and post-operative protocol will be consistent with typical protocol at OIC.

All surgeries will be performed at the outpatient surgery center at OIC. Prior to surgery each patient will be randomized into one of two treatment groups. The group selected to undergo regional anesthesia will receive a single-stick ultrasound-guided infraclavicular nerve block to the affected extremity by a fellowship-trained pediatric anesthesiologist in the operating room using standard sterile technique. For each block ropivacaine 0.5% will be administered up to a max of 0.5 mL/kg until appropriate US-guided spread is achieved. Block duration and volume of ropivacaine used will be recorded, as will any immediate complications encountered (e.g. failed block). Participants randomized to the no regional anesthesia group will not receive any additional anesthetic prior to surgery and will undergo OIC's standard preoperative protocol. All patients in both groups will receive general anesthesia per standard protocol. All patients will undergo open reduction and percutaneous pinning using 2-3 pins placed laterally by two pediatric orthopedic surgeons (Dr. Mauricio Silva and Dr. Rachel Thompson). Participants will all be placed in posterior long arm splints thereafter and made non-weight bearing in that extremity. The patients will be transferred to OIC's post-anesthesia care unit (PACU), where morphine IV 0.1mg/kg will be utilized as needed before discharge home. Nursing staff will record the amount of pain medication provided in the PACU, as well as the pre-discharge pain scores, as is typical post-operative protocol. Prior to discharge a prescription for oxycodone solution 0.1 mg/kg PO q4-6 hours as needed will be given to all participants in both groups with instructions on medication administration and how to fill out the home medication log as per typical OIC post-operative protocol.

Post-operatively, the parents of each participant will be asked to use the Faces Pain Scale-Revised (FPS-R) to rate the child's level of pain at 24 hours and 48 hours after surgery. A research team member will call each participant's guardian at 24 and 48 hours post-operatively to collect these responses. Parents will further be asked to complete the modified Total Quality Pain Management Instrument (TQPM) regarding their level of satisfaction with surgery and post-operative pain control. Parents will be asked to report any side effects (e.g. nausea, vomiting, lethargy, constipation) associated with the medications. Parents will also be asked about any side effects (e.g. swelling, redness, hematoma, prolonged block) from the regional anesthesia. A take-home medication log will be utilized by the parents to record the type and amount of mediation given to each participant and to record any associated side effects.

Conditions

Fractures, Closed; Humeral Fractures; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Infraclavicular Regional Block

This group is given ropivacaine 0.5% up to a max of .5 ml/kg until appropriate ultrasound guided spread is achieved.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine

Puncture Wound

This group is given the same puncture wound and dressing given to the experimental group.

Group Type: SHAM_COMPARATOR

Puncture Wound and Dressing

Intervention Type: OTHER

No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture

Interventions

Ropivacaine

Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine

Intervention Type: DRUG

Puncture Wound and Dressing

No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Isolated lateral condyle humerus fracture
• Closed lateral condyle humerus fracture
• Weiss classification type II and III (>2mm displacement) lateral condyle fractures
• Fractures treated with open reduction percutaneous pinning requiring fixation

Exclusion Criteria

• Open fractures
• Fractures with concomitant vascular or neurologic deficit
• Pathologic fractures
• Those presenting with concomitant injuries
• Swelling requiring post-operative hospitalization for monitoring
• Any known history of allergies to ropivacaine or oxycodone
• Patients with developmental delay that would preclude participation in the visual analog Faces Pain Scale-Revised

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Silva

Mauricio Silva, M.D., Associate Clinical Professor, UCLA/Orthopaedic Institute for Children Department of Orthopaedic Surgery, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Orthopaedic Institute for Children

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Johanthan You, BS

Role: CONTACT

JohnathanYou@mednet.ucla.edu

(213) 742-1074

Facility Contacts

Mauricio Silva, MD

Role: primary

msilva@mednet.ucla.edu

213-742-1369

Samantha C Bauer, MS

Role: backup

SBauer@mednet.ucla.edu

2137426537 ext. 6537

Other Identifiers

18-001552

Identifier Type: -

Identifier Source: org_study_id